FDA Reports Progress in Reviewing E-Cigarette Marketing Applications, But Must Step Up Enforcement Against Illegal Products that Harm Kids

FDA Reports Progress in Reviewing E-Cigarette Marketing Applications, But Must Step Up Enforcement Against Illegal Products that Harm Kids

Statement of Dennis Henigan, Vice President of Legal and Regulatory Affairs, Campaign for Tobacco-Free Kids
July 23, 2024

WASHINGTON, D.C. - In a status report filed on Monday, the FDA told a federal court that it has taken action on 185 of 186 marketing applications for e-cigarette products covered by a 2022 court order, which applied to products with significant market share that filed applications by September 9, 2020.

While this report represents an overdue step forward, the fact is that FDA still has not completed review of these products almost four years after the September 9, 2021, deadline set by the federal court in Maryland and over a year after FDA's own original projected date for completion of review (June 30, 2023), as previously reported to the court. The government's report is a reminder of the history of FDA's delays that have allowed e-cigarettes that are addicting our kids to remain on the market for years without the FDA authorization required by the Tobacco Control Act.

In addition, the FDA still is not doing nearly enough to clear the market of the flavored e-cigarettes that continue to attract and addict our nation's kids. Manufacturers continue to introduce thousands of illegal e-cigarette products without the required authorization by the FDA. Most of these products are sold in kid-friendly flavors, and they deliver massive doses of nicotine that can quickly addict kids. Making matters even worse, manufacturers are now introducing e-cigarette products with video games and other smartphone-like features that make them even more appealing to kids, as a recent report in the journal Tobacco Control revealed. It is unacceptable that the FDA is allowing the introduction of these illegal, unauthorized products that are clearly aimed at kids.

To protect our kids, the FDA, the U.S. Department of Justice and other agencies must greatly step up their enforcement efforts and use all the tools at their disposal to clear the market of these illegal products, as 78 public health and other organizations called for in a recent letter. The FDA has authorized the sale of only 34 e-cigarette products and stated that these are the only products that may be lawfully sold in the U.S. Such statements are meaningless without comprehensive action to clear the market of illegal e-cigarette products.

It is also critical that the FDA quickly issue a final decision on the pending marketing applications for Juul products, which were filed nearly four years ago. After initially denying Juul's applications in June 2022, the FDA recently rescinded its marketing denial order and returned Juul's applications to pending status. The FDA should swiftly finish its review and again deny marketing applications for all Juul products, including its menthol-flavored product, given Juul's primary role in causing the youth e-cigarette epidemic and the continuing popularity of Juul's products among youth.